FREEZE Cohort Study

NCT01360008 | Completed DMC

• 1 other identifier: FREEZE
• Study Type: observational
• Target: 4,071
• Locations: 6 countries
• Sites: 37

Brief Summary

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Conditions

Arrhythmia

Keywords

Cardiac arrhythmia; Catheter ablation; Cohort Study; cryoballoon; radiofrequency

Outcome Measures

Primary Outcomes (1)

• AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up

  Admission to hospital until 12 months thereafter

Secondary Outcomes (5)

• Comparison of complication rates (any complications and major complications) at 12 months follow-up

  Admission to hospital until 12 months thereafter

• Specific complication aspects with respect to phrenic nerve palsy and PV stenosis

  Admission to Hospital until 12 months thereafter

• Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins

  Admission to Hospital until 12 months thereafter

• Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI

  Admission to Hospital until 12 months thereafter

• Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure

  Admission to Hospital until 12 months thereafter

Study Arms (2)

Cryo ablation

Patients with first Ablation of atrial fibrillation treated by cryo ablation

RF ablation

Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF ablation targeting

You may qualify if:

• Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting \< 1 year)
• First ablation of AF
• Age ≥18 years
• Documented inefficacy of at least 1 AAD not including β-blockers
• Written informed consent

You may not qualify if:

• Longstanding persistent AF lasting \> 1 year
• Acute coronary syndrome (ACS)
• Heart failure NYHA IV
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• Stroke or TIA within 6 months prior to ablation
• Uncontrolled hyperthyroidism
• Pregnancy
• Life expectancy \< 1 year

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Medtronic: collaborator

Study Sites (37)

Mission Hospital, Inc.

Asheville, North Carolina, 28803, United States

Location

Allgemeines KH Linz

Linz, 4020, Austria

Location

Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II

Bad Neustadt an der Saale, 97616, Germany

Location

Herz- und Diabeteszentrum

Bad Oeynhausen, Germany

Location

Deutsches Herzzentrum Berlin (Kardiologie)

Berlin, 13353, Germany

Location

Vivantes Klinikum Am Urban

Berlin, Germany

Location

Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin

Bielefeld, 33604, Germany

Location

Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)

Bonn, 53105, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

St. Vinzenz Hospital Köln-Nippes

Cologne, 50733, Germany

Location

Praxisklinik Herz und Gefäße

Dresden, Germany

Location

Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie

Essen, 45138, Germany

Location

Städt. Klinikum Frankfurt Höchst

Frankfurt, 65929, Germany

Location

Cardioangiologisches Centrum Bethanien - CCB

Frankfurt, Germany

Location

Universitäres Herzzentrum Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Universitäres Herzzentrum

Hamburg, Germany

Location

Klinikum Siloah

Hanover, 30449, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Städt. Klinikum Hildesheim

Hildesheim, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, Germany

Location

Universitätsklinik Schleswig-Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Isar Herzzentrum München

München, Germany

Location

Krankenhaus München Bogenhausen

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Klinikum Traunstein

Traunstein, 83278, Germany

Location

Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

Location

Evangelismos General Hospital

Athens, 106 76, Greece

Location

Sunninghill Hospital

Johannesburg, 2196, South Africa

Location

Panorama Medi-Clinic

Panorama, 7500, South Africa

Location

Milpark Hospital

Parktown West, 2193, South Africa

Location

University Hospital Virgen de la Arrixaca

El Palmar - Murcia, 30120, Spain

Location

Related Publications (5)

• Pongratz J, Kuniss M, Wu L, Tebbenjohanns J, Nolker G, Dorwarth U, Kuck KH, Jochen S, Hoffmann E, Straube F; FREEZE Cohort Study Investigators. Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study. J Cardiovasc Electrophysiol. 2023 Oct;34(10):2029-2039. doi: 10.1111/jce.16060. Epub 2023 Sep 8.

  PMID: 37681996 DERIVED

• Metzner A, Straube F, Tilz RR, Kuniss M, Noelker G, Tebbenjohanns J, Andresen D, Wieneke H, Stellbrink C, Franke J, Dorwarth U, Carion PL, Holbrook R, Hochadel M, Senges J, Hoffmann E, Kuck KH; FREEZE Cohort Study Investigators. Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study. BMC Cardiovasc Disord. 2023 Jan 9;23(1):8. doi: 10.1186/s12872-022-03015-8.

  PMID: 36624380 DERIVED

• Hoffmann E, Straube F, Wegscheider K, Kuniss M, Andresen D, Wu LQ, Tebbenjohanns J, Noelker G, Tilz RR, Chun JKR, Franke A, Stellbrink C, Garcia-Alberola A, Dorwarth U, Metzner A, Ouarrak T, Brachmann J, Kuck KH, Senges J; FREEZE Cohort Study Investigators. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. Europace. 2019 Sep 1;21(9):1313-1324. doi: 10.1093/europace/euz155.

  PMID: 31199860 DERIVED

• Straube F, Dorwarth U, Ammar-Busch S, Peter T, Noelker G, Massa T, Kuniss M, Ewertsen NC, Chun KR, Tebbenjohanns J, Tilz R, Kuck KH, Ouarrak T, Senges J, Hoffmann E; FREEZE Cohort Investigators. First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation. Europace. 2016 Mar;18(3):368-75. doi: 10.1093/europace/euv271. Epub 2015 Oct 25.

  PMID: 26504108 DERIVED

• Straube F, Dorwarth U, Vogt J, Kuniss M, Heinz Kuck K, Tebbenjohanns J, Garcia Alberola A, Chun KR, Souza JJ, Ouarrak T, Senges J, Brachmann J, Lewalter T, Hoffmann E. Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy. Europace. 2014 Oct;16(10):1434-42. doi: 10.1093/europace/euu162. Epub 2014 Jul 3.

  PMID: 24994074 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Hoffmann, MD

  Klinikum Bogenhausen, München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 25, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2017
• Last Updated: June 27, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (1); DE (30); GR (1); AU (1); ZA (3)